Contract analysis

ARTICLE 1 — DEFINITIONS AND INCORPORATION BY REFERENCE

Section 1.1 — Definitions All capitalized terms used but not otherwise defined in this Individual Site Agreement shall have the respective meanings ascribed to such terms in the MCTA. In addition to the defined terms set forth in Article 1 of the MCTA, the following terms shall have the meanings set forth below for purposes of this Individual Site Agreement: (a) "Effective Date" means July 18, 2023, which is the effe

Section 1.2 — Incorporation of MCTA The terms and conditions of the Master Clinical Trial Agreement dated June 28, 2023, by and between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc., including without limitation all Exhibits A through K and Schedule 1 attached thereto and incorporated therein, are hereby incorporated by reference in their entirety into this Individual Site Agreement as if

ARTICLE 2 — SITE DESIGNATION AND SCOPE OF WORK

Section 2.1 — Site Designation Graystone University Medical Center is hereby designated as Site 001 under the MCTA, serving as the lead enrollment site for the CLARION trial. The Institution's principal site address for the conduct of all trial-related activities under Protocol PPC-4871-III is: Graystone University Medical Center 1200 University Avenue Philadelphia, Pennsylvania 19104 All clinical trial activities at

Section 2.2 — Scope of Work The Institution shall conduct the CLARION trial at Site 001 in strict accordance with Protocol PPC-4871-III, as the same may be amended from time to time in accordance with the MCTA, and in compliance with all applicable regulatory requirements, including without limitation the requirements of ICH E6(R2) GCP Guidelines, Title 21 of the United States Code of Federal Regulations, and the con

Section 2.3 — Lead Site Responsibilities In addition to the general obligations applicable to all participating sites under the MCTA, the Institution, in its capacity as the lead enrollment site (Site 001) for the CLARION trial, shall have the following additional responsibilities: (a) Protocol Training. The Institution shall serve as the primary site for the conduct of investigator meetings and protocol training ses

ARTICLE 3 — PRINCIPAL INVESTIGATOR

Section 3.1 — Identification and Qualifications The Principal Investigator for the conduct of the CLARION trial at Site 001 is Dr. Catherine Aldridge, M.D., Ph.D., Professor of Oncology at Graystone University Medical Center. Dr. Aldridge holds an M.D. from the University of Pennsylvania Perelman School of Medicine and a Ph.D. in Molecular Pharmacology from the same institution. She is board-certified in Medical Onco

Section 3.2 — PI Obligations The Principal Investigator shall perform her duties and obligations under this Agreement, the MCTA, and the Protocol with the degree of skill, care, and diligence expected of a qualified investigator conducting a clinical trial in accordance with applicable professional standards and regulatory requirements. Without limiting the generality of the foregoing, the Principal Investigator shal

Section 3.3 — Replacement of PI The Institution shall not replace the Principal Investigator without the prior written consent of the Sponsor, which consent shall not be unreasonably withheld, conditioned, or delayed, provided that the proposed replacement investigator meets the Sponsor's qualification requirements as set forth in the Protocol and the MCTA. In the event of the Principal Investigator's unavailability

ARTICLE 4 — IRB APPROVAL AND REGULATORY COMPLIANCE

Section 4.1 — IRB of Record The Graystone University Institutional Review Board (IRB Registration Number: IRB00012847) shall serve as the Institutional Review Board of record for the conduct of the CLARION trial at Site 001. The Parties acknowledge that Graystone University Medical Center requires individual institutional IRB approval for all clinical research conducted at its facilities and does not rely upon the Ve

Section 4.2 — IRB Approval as Condition Precedent IRB approval of Protocol PPC-4871-III, the informed consent form (including any site-specific modifications approved by the Sponsor), and all subject-facing materials (including recruitment materials, subject diaries, and patient information sheets) by the Graystone University IRB is a condition precedent to the enrollment of any subject at Site 001. No screening or e

Section 4.3 — Ongoing IRB Compliance The Institution and the Principal Investigator shall maintain continuous IRB approval throughout the entire duration of the conduct of the CLARION trial at Site 001, from the date of initial approval through the completion of all trial-related activities, including the follow-up period and the final data lock. Without limiting the foregoing, the Institution and PI shall: (a) Submi

Section 4.4 — Regulatory Compliance Representations The Institution represents and warrants to the Sponsor and the Network that the Institution and the Principal Investigator are, and throughout the term of this Agreement shall remain, in compliance with all applicable federal, state, and local laws, regulations, and guidelines governing the conduct of clinical trials, including without limitation: (a) Title 21, Code

ARTICLE 5 — BUDGET AND PAYMENT

Section 5.1 — Site-Specific Budget The financial terms applicable to the conduct of the CLARION trial at Site 001 are set forth in Exhibit B (Budget and Payment Schedule) to the MCTA and in the Site-Specific Budget Schedule attached hereto as Appendix B, which are incorporated herein by reference. In the event of any conflict between the general budget provisions of Exhibit B to the MCTA and the site-specific provisi

Section 5.2 — Start-Up Fees The Sponsor shall pay the Institution a non-refundable start-up fee of Seventy-Five Thousand Dollars ($75,000) in connection with the initiation of the CLARION trial at Site 001. The start-up fee shall cover all costs associated with site preparation, IRB submission and review, staff training, source document template preparation, pharmacy set-up, and other pre-enrollment activities. The s

Section 5.3 — Annual Site Maintenance Fees In addition to the per-patient site fees and start-up fees described above, the Sponsor shall pay the Institution an annual site maintenance fee of Forty Thousand Dollars ($40,000) per year during the term of this Agreement. The annual site maintenance fee shall cover the Institution's ongoing overhead costs, including site infrastructure, regulatory document maintenance, IR

Section 5.4 — Payment Terms All payments to the Institution under this Agreement shall be made within forty-five (45) calendar days of the Sponsor's receipt of a proper invoice submitted by the Institution (Net 45 days). Each invoice shall set forth in reasonable detail the basis for the payment requested, including the applicable milestone, the subject identification number(s) (where applicable), and the amount due.

Section 5.5 — Network Coordination Fee The Parties acknowledge that the network coordination and administrative fee payable by the Sponsor to the Veridian Health Research Network in the aggregate amount of Four Million Two Hundred Thousand Dollars ($4,200,000), payable in quarterly installments of Three Hundred Thousand Dollars ($300,000) each over fourteen (14) quarters, is governed exclusively by the terms of the M

Section 5.6 — Investigator Grants Investigator grants for academic publication support and dissemination of scientific findings, in the aggregate amount of One Million Five Hundred Thousand Dollars ($1,500,000) across all participating Veridian Network sites, shall be disbursed upon acceptance of manuscripts for publication in peer-reviewed scientific journals, in accordance with the terms and conditions set forth in

Section 6.1 — Sponsor Indemnification of Site and Investigators Subject to the terms and conditions of this Article 6 and Exhibit D (Subject-Injury Indemnification Provisions) of the MCTA, Penterra Pharmaceuticals Corp. shall defend, indemnify, and hold harmless the Institution, the Principal Investigator, all sub-investigators, and all study staff at Site 001 (collectively, the "Site Indemnitees") from and against a

Section 6.2 — Carve-Outs from Sponsor Indemnification Notwithstanding anything to the contrary in Section 6.1, the Sponsor's indemnification obligations under this Article 6 shall not extend to, and the Sponsor shall have no obligation to defend, indemnify, or hold harmless any Site Indemnitee with respect to, any Losses to the extent arising from or attributable to: (i) The negligence, gross negligence, recklessness

Section 6.3 — Subject Medical Care Costs In addition to its indemnification obligations under Section 6.1, Penterra shall reimburse or pay directly the reasonable and customary medical costs incurred for the diagnosis and treatment of study-related injuries sustained by subjects enrolled in the CLARION trial at Site 001, to the extent that such costs are not covered by the subject's health insurance or other third-pa

Section 6.4 — Product Defect Claims Notwithstanding the caps set forth in Section 6.3, the Sponsor's indemnification obligations with respect to Losses arising from defects in the Investigational Product (as described in Section 6.1(b)) shall not be subject to any per-subject cap or aggregate cap. The Sponsor's liability for product defect claims shall be unlimited in amount, and the Sponsor shall fully indemnify, de

Section 6.5 — Site/Institution Indemnification of Sponsor Subject to the terms and conditions of this Article 6 and Exhibit D of the MCTA, the Institution (acting through the Network, to the extent required by the MCTA) shall defend, indemnify, and hold harmless Penterra Pharmaceuticals Corp., its officers, directors, employees, agents, and affiliates (collectively, the "Sponsor Indemnitees") from and against any and

Section 6.6 — Notice Requirements The Party seeking indemnification (the "Indemnified Party") shall provide written notice to the Party from whom indemnification is sought (the "Indemnifying Party") within thirty (30) calendar days of becoming aware of any claim, demand, action, suit, or proceeding for which indemnification may be sought under this Article 6. Such notice shall include a description of the claim in re

Section 6.7 — Cross-Reference The detailed indemnification provisions governing the CLARION trial, including the procedures for defense, settlement, and payment of claims, are set forth in Exhibit D (Subject-Injury Indemnification Provisions) to the MCTA, which is incorporated herein by reference. In the event of any conflict between this Article 6 and Exhibit D, Exhibit D shall control.

Section 7.1 — Sponsor Insurance Penterra Pharmaceuticals Corp. represents and warrants that it maintains clinical trial liability insurance through Briarcliff Mutual Insurance Company, under Policy No. BM-CTL-2023-04182, providing coverage for claims arising from the conduct of the CLARION trial, with the following coverage limits: • Per-Occurrence Limit: Twenty-Five Million Dollars ($25,000,000) • Aggregate Limit: S

Section 7.2 — Site Insurance The Institution shall maintain, at its own expense and throughout the term of this Agreement, general liability and professional liability (medical malpractice) insurance coverage with limits of not less than: • Per-Occurrence Limit: Five Million Dollars ($5,000,000) • Aggregate Limit: Ten Million Dollars ($10,000,000) Such insurance shall be obtained from a carrier or carriers rated A- (

Section 7.3 — Certificate Exchange The requirements for insurance certificates, the form of certificates, and the procedures for the exchange of insurance documentation are set forth in Exhibit E (Insurance Requirements and Certificate Forms) to the MCTA, which is incorporated herein by reference.

ARTICLE 8 — DATA OWNERSHIP, RECORDS, AND CONFIDENTIALITY

Section 8.1 — Data Ownership The Institution acknowledges and agrees that Penterra Pharmaceuticals Corp. retains exclusive ownership of all clinical trial data generated at Site 001 under Protocol PPC-4871-III, including without limitation all case report form data (whether entered into the EDC Platform or recorded on paper source documents), laboratory data, imaging data, pharmacokinetic and pharmacodynamic data, bi

Section 8.2 — Source Document Retention The Institution shall retain all original source documents, essential documents, and regulatory files relating to the conduct of the CLARION trial at Site 001 for a minimum period of fifteen (15) years following the completion of the trial at this Site (including the completion of all follow-up activities and resolution of all data queries), or for such longer period as may be

Section 8.3 — Electronic Data Capture All clinical trial data generated at Site 001 shall be entered by authorized site personnel into the EDC Platform provided by Pinnacle Data Solutions, Inc., in accordance with the data management plan, data entry guidelines, and query resolution procedures established by the CRO (Meridian Contract Research Organization, Inc.). The Institution shall ensure that all site personnel

Section 8.4 — Central Laboratory All biological specimens collected at Site 001 for the purposes of pharmacokinetic, pharmacodynamic, biomarker, and safety laboratory analyses under Protocol PPC-4871-III shall be processed, stored, and shipped to Northbridge Bioanalytical Laboratories, Inc. (the Central Laboratory) in accordance with the laboratory manual provided by the Sponsor and the specimen handling and shipping

Section 8.5 — Confidentiality All information disclosed by the Sponsor, the Network, or the CRO to the Institution or the Principal Investigator in connection with the CLARION trial, including without limitation the Protocol, the Investigator's Brochure, Investigational Product specifications, manufacturing information, preclinical and clinical data, Study Data, statistical analyses, regulatory strategies, business p

Section 8.6 — HIPAA Compliance The Institution shall comply with all applicable requirements of the Health Insurance Portability and Accountability Act of 1996, as amended ("HIPAA"), and its implementing regulations at Title 45, Code of Federal Regulations, Parts 160 and 164, including the Standards for Privacy of Individually Identifiable Health Information (the "Privacy Rule"), the Security Standards for the Protec

ARTICLE 9 — INTELLECTUAL PROPERTY AND PUBLICATION RIGHTS

Section 9.1 — Pre-Existing IP Each Party shall retain exclusive ownership of, and all rights in and to, its pre-existing intellectual property, including all patents, patent applications, copyrights, trade secrets, know-how, trademarks, and other proprietary rights that were owned by or licensed to such Party prior to the Effective Date of this Agreement (collectively, "Pre-Existing IP"). Nothing in this Agreement or

Section 9.2 — Joint Inventions The ownership, licensing, and commercialization of any inventions, discoveries, improvements, or other intellectual property rights that arise during or as a result of the conduct of the CLARION trial at Site 001, whether made solely by the Institution or the PI, solely by the Sponsor, or jointly by the Institution or PI and the Sponsor (collectively, "Trial IP"), shall be governed by t